Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures
This is a randomized two-arms cross-over trial. In this study there are two groups, the
control group and the triamcinolone treatment group. The cross-over design will apply only
in the control group when patients are not responding to EGD dilations alone (defined as no
sustained improvement in baseline dysphagia) and they will be allowed to cross-over to the
triamcinolone group and undergo 3 successive EGDs with triamcinolone injection.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period
The main outcome measured will be number of visits to receive Esophageal Dilation during the 12-month follow-up period. Successful dilation of the stricture for the procedure will be defined as creation of a mucosal tear confirmed by endoscopic visualization after the last dilation is performed.
Jason Klapman, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Northwestern University Medical Center||Chicago, Illinois 60611|
|UCLA Medical Center||Los Angeles, California 90095-7059|
|California Pacific Medical Center||San Francisco, California 94115|